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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004228 |
Receipt No. | R000005083 |
Scientific Title | Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients |
Date of disclosure of the study information | 2010/10/31 |
Last modified on | 2012/03/17 |
Basic information | ||
Public title | Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients | |
Acronym | HT for swallowing reflex and prevention of pneumonia in brain disease | |
Scientific Title | Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients | |
Scientific Title:Acronym | HT for swallowing reflex and prevention of pneumonia in brain disease | |
Region |
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Condition | ||||
Condition | post cerebrovascular disease, neurodegenerative diseases e.g. PD, SCD, ALS | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effects of BHT for swallowing refles disorder and preventing aspiration pneumonia in brain disease patients |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | wallowing reflex, pneumonia onset |
Key secondary outcomes | days with fever over 37.5, self-feeding |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Taking BHT (traditional Chinese medicine) 8weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.elderly patients with brain diseases
2.Swallowing reflex can be tested 3.Aspiration pneumonia history at least 1 time 4.Transaminases are less than twice of w.n.l. 5.Cre less than 2.0 6.Stable status and will survive more than 3 months after baseline 7.With informed concent and agreement from patients or family members |
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Key exclusion criteria | 1.Patients having malignancy, severe heart diseases and other factors that would influence the results.
2.Chronic respiratory diseases e.g. BA, COPD 3.Without agreement of patients or family members |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tagami memorial hospital | ||||||
Division name | Internal medicine | ||||||
Zip code | |||||||
Address | Nisibeppucho 1779, Kagoshima City | ||||||
TEL | 099-282-0051 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Tagami memorial hospital | ||||||
Division name | Internal medicine | ||||||
Zip code | |||||||
Address | Nisibeppucho 1779, Kagoshima City | ||||||
TEL | 099-282-0051 | ||||||
Homepage URL | |||||||
yoshinobu_takemoto@shunpukai.com |
Sponsor | |
Institute | Dept. of traditional Asian medicine, Postgraduate school of medicine, Tohoku University |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | National Yonezawa hospital |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | Tagami memorial Hospital, Kagoshima Prefacture, National Yonezawa hospital, Yamagata Pref |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://jglobal.jst.go.jp/public/20090422/201102220184329522 |
Number of participants that the trial has enrolled | |
Results | Hangekobokuto improved the swallowing refex and decrease the pneumonia onset. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005083 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |